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May 10, 2007 -- An expert panel on Thursday urged the FDA to further rein in
doctors' use of drugs that stimulate red blood cells because of mounting
evidence that the medications cause some patients to die early.

The experts called for new warnings on anemia drugs used to boost production
of red blood cells. The move comes only weeks after the agency warned the
public that the drugs may speed cancer growth and spur heart attacks and other
cardiovascular problems.

The drugs were approved because of their ability to lower the need for blood
transfusions in cancer patients who have anemia (low red blood cell count) due
to chemotherapy. But clinics and hospitals have seen an explosion in use of
these drugs that FDA scientists and cancer experts say has gone beyond the
state of scientific knowledge.

Experts Thursday complained that aggressive industry marketing to doctors
and patients has prompted overuse of the drugs and may be contributing to
safety problems.

In March, the FDA placed "black box" warnings on the three drugs
available in the U.S.: Epogen, Procrit, and Aranesp. The warnings alert
patients and doctors to lessen the risk of blood clots by using the lowest dose
of medication needed to avoid the need for blood transfusion.

The boxed warning also includes information that the drugs can increase the
risk of death or serious medical complication such as heart attacks and strokes
if used too aggressively in some patients.

Overuse Alleged

Most evidence suggests that the increased risks are the result not of
recommended use, but instead are due to overdosing and overprescribing to a
largely unstudied swath of patients. As many as 450,000 American patients are
taking the drugs, which can cost $1,000 per treatment.

Many doctors prescribe the drugs to improve quality of life by helping with
the fatigue often resulting from anemia. But FDA scientists said Thursday that
no scientific studies have shown the drugs improve cancer patients' quality of
life.

At the same time, evidence from at least two recent studies showed they may
promote tumors and cause early death, says Vinni Juneja, an agency safety
official.

"FDA believes there should be a reconsideration of the risk to benefit
ratio ... in cancer patients," he says.

Industry scientists maintain that the drugs can improve quality of life and
don't spur cancer growth.

"We do not have data that tumor progression is an issue as a result of
erythropoietin treatment. We simply don't," says Roger M. Perlmutter, MD,
executive vice president of Amgen, which sells Epogen.

Marketing Questioned

But agency officials and experts blamed aggressive industry marketing for
promoting the drugs as a way to boost energy -- a claim not approved by the
FDA.

Television and print advertisements widely distributed by Procrit maker
Johnson & Johnson urged patients to seek out the drug as a way to improve
vigor.

"Most doctors and most patients think this drug has been approved
because it improves quality of life, it improves fatigue. There's a lot of
sleight of hand here on how the drug is used ... and that's a problem,"
says Otis Brawley, MD, a professor of oncology at Winship Cancer Institute at
Emory University in Atlanta and a member of the panel.

Maha H.A. Hussein, MD, the panel's chairwoman, says she doesn't want to see
the drugs pulled from the market because they are important for "supportive
care." But she also suggests that company marketing has urged doctors to
give higher-than-recommended doses under the assumption that boosting red blood
cell counts translated to more comfort for patients.

"We started out with a huge problem, which is the ad campaign
problem," says Hussein, a professor of medicine at the University of
Michigan.

Doctors are allowed to prescribe drugs for any reason, but FDA regulations
forbid companies from promoting drugs for unapproved uses.

Richard Pazdur, MD, head of the FDA office in charge of cancer drugs, says
agency officials are looking into why apparently aggressive promotional
campaigns were left unchecked.

"There's a lot of concern that these are being promoted with
quality-of-life claims that are not in the label," he says. "I think
they need to give the American public a clear understanding as to why these ads
were allowed to continue."

Experts Thursday urged the agency to go further in restricting use of the
drugs in cancer patients, though they provided little clear guidance on what
those restrictions should be. Experts said the agency should consider
discouraging the drugs' use in patients with several forms of cancer. They also
urged that doctors be warned to discontinue using the drugs once chemotherapy
is stopped.

The FDA's actions depend in large part on the results of several ongoing
studies, Pazdur says.

The drugs are also approved for use in patients with kidney failure. FDA
officials said they were planning a public review of the drugs' safety in those
patients for the fall.

"We will be working the FDA as they consider the committee's
recommendations," says Amgen spokeswoman Trish Hawkins.